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Testing long-term nerve stimulation through the ear

Researchers test stimulation of a nerve through the skin of the ear in early Parkinson’s, comparing it with a control treatment.

Testing a treatment or activity · Study reference: NCT06665113

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Looking for volunteers

Start (reported actual date)
2024-12-23
Main measurements finished (planned)
2026-06
Study finished (planned)
2026-06

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 55 years to 75 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: 1. Age 55-75 years. 2. Clinically diagnosed Idiopathic Parkinson's disease patients according to the 2016 Chinese diagnostic criteria for Parkinson's disease. 3. Hoehn and Yahr (H\&Y) stage ≤ 2.5 at medication initiation. 4. Parkinson's disease duration ≤ 3 years. 5. Receiving standard anti-Parkinson's disease medication treatment. Exclusion Criteria: 1. Patients with cognitive impairment (MMSE \< 24 and/or MoCA \< 26) or mental illnesses, or those unable to cooperate for other reasons. 2. Use of neuroprotective medications within 90 days prior to baseline, including monoamine oxidase B inhibitors (rasagiline, selegiline), certain dopamine receptor agonists (ropinirole), and GLP-1 receptor agonists such as Exenatide and NLY-01. 3. Use of any medications that may affect dopamine metabolism and/or dopamine receptors within 90 days prior to baseline, including typical and atypical antipsychotics, metoclopramide, α-methyl-dopa, flunarizine, apomorphine, amphetamine derivatives, bupropion, buprenorphine, cocaine, meperidine, methamphetamine, norephedrine, phentermine, modafinil, methylphenidate, procyclidine, reserpine, phenylpropanolamine, or MAO-A inhibitors. 4. Previous treatment with vagus nerve stimulation. 5. MRI contraindications (e.g., claustrophobia unresponsive to comfort or low-dose anxiolytics, dental implants) or MRI scans indicating clinically significant abnormalities in the brain, including but not limited to past hemorrhages or infarcts \> 1 cm³ or \> 3 lacunar infarcts. 6. Contraindications for taVNS, such as patients with cardiac pacemakers or a history of DBS surgery, or those planning surgery during the trial; ear conditions, such as tympanic membrane perforation. 7. Atypical or secondary Parkinsonian syndromes, including but not limited to those caused by trauma, brain tumors, infections, cerebrovascular diseases, or other neurological disorders, or symptoms confirmed by the investigator as drug, chemical, or toxin-related. 8. Previous history of stroke or intracranial mass lesions. 9. Patients with existing or potential cardiovascular diseases. 10. Ophthalmic diseases affecting eye movements. 11. Any neurological disorders other than Parkinsonian motor symptoms that interfere with gait or balance (e.g., chronic pain) or musculoskeletal injuries (e.g., fractures, stroke sequelae). 12. Severe organic diseases, such as late-stage tumors, with a life expectancy of less than 2 years. 13. Concurrent participation in other clinical trials. 14. Inability to receive the required treatment and follow-up due to geographic reasons. 15. Any subject with an upper limb UPDRS tremor score of 3 or higher. 16. Patients with a history of PD-related freezing episodes or falls.
Full study name & original research details

Official study title

A Double-blinded, Randomized, Parallel-group, Superiority Study to Explore the Neuroprotective Effects of Long-term Transcutaneous Auricular Vagus Nerve Stimulation(taVNS) in Early Parkinson's Disease(PD) Patients

Short title used by the registry

Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients

Original description

This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease.

Further description from the registry

This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease, , aiming to investigate a novel therapeutic approach for delaying PD progression.

Conditions reported: Parkinson Disease, Idiopathic

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
taVNS real stimulation; taVNS sham stimulation
Phases
NA
Sponsor
Kezhong Zhang
Start date reported by registry
2024-12-23 (actual)

Registry updated: 2025-01-14 · Status last verified by the registry submitter: 2025-01

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Kezhong Zhang, Professor · 400-13770840575 · kezhong_zhang1969@126.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Recruiting

Kezhong Zhang · 13770840575 · kezhong_zhang1969@126.com

Facility not reported

China

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.